Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes
| Verified date | February 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in Europe.
The aim of this research study is to compare the efficacy of adding inhaled preprandial
insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type
2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin
antibodies and side effects).
| Status | Terminated |
| Enrollment | 301 |
| Est. completion date | March 5, 2008 |
| Est. primary completion date | March 5, 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes - Treated with OAD(s) for more than or equal to 2 months - Body mass index of (BMI) less than or equal to 40.0 kg/m2 - HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% and less than or equal to 10.0 % for subjects on OAD combination therapy Exclusion Criteria: - Recurrent major hypoglycaemia - Current smoking or smoking within the last 6 months - Impaired hepatic or renal function - Cardiac disorders - Uncontrolled hypertension - Proliferative retinopathy or maculopathy |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novo Nordisk Investigational Site | Ebreichsdorf | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Finland | Novo Nordisk Investigational Site | Joensuu | |
| Finland | Novo Nordisk Investigational Site | Kirkkonummi | |
| Finland | Novo Nordisk Investigational Site | Turku | |
| France | Novo Nordisk Investigational Site | Corbeil Essonnes | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Mougins | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | Pessac | |
| France | Novo Nordisk Investigational Site | Pointe à Pitre | |
| France | Novo Nordisk Investigational Site | Roubaix | |
| France | Novo Nordisk Investigational Site | Tours | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| Germany | Novo Nordisk Investigational Site | Aschaffenburg | |
| Germany | Novo Nordisk Investigational Site | Augsburg | |
| Germany | Novo Nordisk Investigational Site | Bad Mergentheim | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Darmstadt | |
| Germany | Novo Nordisk Investigational Site | Dormagen | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Duisburg | |
| Germany | Novo Nordisk Investigational Site | Flörsheim | |
| Germany | Novo Nordisk Investigational Site | Frankfurt | |
| Germany | Novo Nordisk Investigational Site | Fulda | |
| Germany | Novo Nordisk Investigational Site | Genthin | |
| Germany | Novo Nordisk Investigational Site | Hermaringen | |
| Germany | Novo Nordisk Investigational Site | Kutenholz-Mulsum | |
| Germany | Novo Nordisk Investigational Site | Münster | |
| Germany | Novo Nordisk Investigational Site | Pirna | |
| Germany | Novo Nordisk Investigational Site | Schkeuditz | |
| Germany | Novo Nordisk Investigational Site | Wangen | |
| Germany | Novo Nordisk Investigational Site | Wiesbaden | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Ireland | Novo Nordisk Investigational Site | Waterford | |
| Netherlands | Novo Nordisk Investigational Site | Delft | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Drachten | |
| Netherlands | Novo Nordisk Investigational Site | Rijswijk | |
| Netherlands | Novo Nordisk Investigational Site | Roelofarendsveen | |
| Netherlands | Novo Nordisk Investigational Site | Vlodrop | |
| Netherlands | Novo Nordisk Investigational Site | Zwijndrecht | |
| Spain | Novo Nordisk Investigational Site | Alcira | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Gijón | |
| Spain | Novo Nordisk Investigational Site | Majadahonda | |
| Spain | Novo Nordisk Investigational Site | Palma de Mallorca | |
| Spain | Novo Nordisk Investigational Site | Partida de Bacarot | |
| Spain | Novo Nordisk Investigational Site | Pontevedra | |
| Spain | Novo Nordisk Investigational Site | Reus | |
| Spain | Novo Nordisk Investigational Site | San Juan | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Switzerland | Novo Nordisk Investigational Site | Interlaken-Unterseen | |
| Switzerland | Novo Nordisk Investigational Site | Olten | |
| Switzerland | Novo Nordisk Investigational Site | Zürich | |
| United Kingdom | Novo Nordisk Investigational Site | Aberdeen | |
| United Kingdom | Novo Nordisk Investigational Site | Bath | |
| United Kingdom | Novo Nordisk Investigational Site | Belfast | |
| United Kingdom | Novo Nordisk Investigational Site | Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Bradford-on-Avon | |
| United Kingdom | Novo Nordisk Investigational Site | Guildford | |
| United Kingdom | Novo Nordisk Investigational Site | Hull | |
| United Kingdom | Novo Nordisk Investigational Site | Northampton | |
| United Kingdom | Novo Nordisk Investigational Site | Salford | |
| United Kingdom | Novo Nordisk Investigational Site | Swansea | |
| United Kingdom | Novo Nordisk Investigational Site | Trowbridge | |
| United Kingdom | Novo Nordisk Investigational Site | Trowbridge | |
| United Kingdom | Novo Nordisk Investigational Site | Wirral, Merseyside | |
| United Kingdom | Novo Nordisk Investigational Site | York |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Austria, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment difference in HbA1c | After 26 weeks | ||
| Secondary | Adverse events | For the duration of the trial | ||
| Secondary | Body weight | For the duration of the trial | ||
| Secondary | Lung function | For the duration of the trial | ||
| Secondary | Blood glucose | For the duration of the trial | ||
| Secondary | Hypoglycaemia | For the duration of the trial |
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